BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0FC SIGMA STAB INS SZ4 10MM

    MDR report key: 671954 · Received February 2, 2006

    Report

    Report Number
    1818910-2006-00204
    Event Type
    Injury
    Date Received
    February 2, 2006
    Date of Event
    January 12, 2006
    Report Date
    January 12, 2006
    Manufacturer
    DEPUY-NEW BEDFORD, DIV OF DEPUY ORTHOPAEDICS, INC
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT REVISED DUE TO OSTEOLYSIS, POLYWEAR AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0FC SIGMA STAB INS SZ4 10MM TOTAL KNEE REPLACEMENT JWH DEPUY-NEW BEDFORD, DIV OF DEPUY ORTHOPAEDICS, INC NA 48983A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention